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Endocare® (Single Care) in Pain-related Endometriosis

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ClinicalTrials.gov Identifier: NCT04650516
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Lucine

Brief Summary:
Endocare® treatment is a stand-alone software medical device, which is composed of a mobile application and an accessory VR headset, intended to mitigate the pain for patients prone to endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Pain Device: Virtual reality Device: Digital control Not Applicable

Detailed Description:

Endocare® treatment is a stand-alone software medical device, which is composed of a mobile application and an accessory VR headset, intended to mitigate the pain for patients prone to endometriosis.

Mitigation of pain is realized through sequences of treatments via audio and visual stimulations.

The Endocare® treatment's main functionality, which addressed the intended purpose, is conducting sequences for treatment to mitigate the pain sensed by the patient.

The software will allow mitigating the sensed pain through 3D Virtual Reality via sequences of environments. The software will emit through sequences of 3D environments, auditory and visual stimulations.

The medical device is a CE marked Class I device. Women suffering from endometriosis present recurrent pelvic pain impairing their quality of life. The endometriosis-related pain has pejorative repercussions on sexual, family and professional life. Currently, the physician armamentarium is limited to analgesics and non-steroid anti-inflammatory drugs to treat endometriosis-related pain. Endocare® treatment intends to relieve pain thanks to its action on central nervous system. This study will describe the evolution of pain in patients experiencing endometriosis-related pain after a single treatment of Endocare® or a digital control.

The use of a digital control as a comparator is the only way to show a specific effect of the Endocare® treatment. Therefore, a digital control displaying visual and auditive sequences with no expected effect will be used for the study. This digital control, for which only a placebo effect may occur, will be displayed on a tablet instead of VR (Colloca et al., 2020).

The main analysis will be performed on an intent-to-treat basis. The statistical analysis will be performed using the SAS 9.4 (or higher) software (SAS Institute, Cary, NC, USA).

Continuous variables will be described by the number of observations, mean, standard deviation, minimum, maximum and median. Categorical variables will be described by the number and percentage of each modality. Percentages will be calculated on the number of observed data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, comparative, open-label, controlled interventional pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Pain Relief in Patients Experiencing Endometriosis-related Pain and Treated With Endocare®
Actual Study Start Date : December 3, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Endocare treatment
Patients will receive the treatment on a dedicated virtual reality headset to display the Endocare® application, with high quality headphones
Device: Virtual reality
20 minutes treatment in virtual reality

Active Comparator: Digital control treatment
Patients will receive the digital control on a dedicated tablet to display the digital control, with high quality headphones
Device: Digital control
20 minutes digital control movie on tablet without virtual reality




Primary Outcome Measures :
  1. Mean pain intensity 60 minutes after the beginning of treatment [ Time Frame: 60 minutes after treatment ]

    Pain assessment evaluated with numerical rating scale (NRS):

    Pain assessed by 11-point numerical rating scale (NRS):

    0=no pain; 10=unbearable pain



Secondary Outcome Measures :
  1. Evaluate the pain evolution after Endocare® compared to the digital control [ Time Frame: baseline (before treatment), 15 minutes, 30 minutes, 45 minutes, and 240 minutes after treatment ]

    Pain assessment evaluated with numerical rating scale (NRS):

    11-point numerical scale (0=no pain; 10=unbearable pain)


  2. Evaluate the pain relief after Endocare ® compared to the digital control [ Time Frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment ]

    The time to reach and maintain pain relief as assessed by the pain relief score ≥ 3

    PRS is a 5-point categorical scale (0: no relief, 1: slight relief, 2: moderate relief, 3: lots of relief and 4: complete relief)

    The event will be defined by the first occurrence of PRS ≥ 3


  3. Evaluate the maximum reduction in pain after Endocare® compared to the digital control [ Time Frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment ]
    The time to reach and maintain pain reduction ≥30% and ≥50% evaluated with NRS 11-point numerical scale (0=no pain; 10=unbearable pain)

  4. Describe the women satisfaction toward Endocare® or the digital control [ Time Frame: 240 minutes after treatment ]

    Satisfaction after using Endocare® compared to the digital control, will be self-rated by the patient on a 7-point Likert scale:

    1: extremely dissatisfied, 2: very dissatisfied, 3: rather dissatisfied, 4: neutral, 5: rather satisfied, 6: very satisfied, 7: extremely satisfied


  5. Evaluate the safety of Endocare® or the digital control [ Time Frame: through study completion, at 240 minutes after treatment ]
    Incidence of adverse events (AE)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman ≥ 18 years old
  • With a diagnosis of endometriosis
  • Willing to participate in the study and having signed the informed consent form
  • Suffering from a moderate-to-severe endometriosis-related pain ≥ 4 on numerical rating scale (NRS) at the time of inclusion

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Woman having consumed painkillers within 8h prior inclusion
  • Woman participating in an interventional study or having participated in an interventional study within the 30 days before enrolment
  • Contraindication to Endocare® or digital control: patients with severe visual, hearing and/or cognitive impairments, patients with colour blindness, patients who are photo-sensitive or suffering from epilepsy or motion sickness
  • Woman being an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04650516


Contacts
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Contact: Garance Dispersyn, PhD 33 6 68 93 45 71 gdispersyn@projet-lucine.org

Locations
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France
Clinique Tivoli Ducos Recruiting
Bordeaux, Gironde, France, 33000
Contact: Benjamin Merlot, MD         
Sponsors and Collaborators
Lucine
Investigators
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Principal Investigator: Benjamin Merlot, MD Clinique Tivoli Ducos
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Responsible Party: Lucine
ClinicalTrials.gov Identifier: NCT04650516    
Other Study ID Numbers: 20206-A01541-38
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis